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Mobile Shared Decision-Making Program for ICU Caregivers

Effectiveness of a Mobile Technology Share Decision-Making Program for Critically Ill Patients' Caregiver in Intensive Care Unit.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07469878
Enrollment
70
Registered
2026-03-13
Start date
2021-08-28
Completion date
2022-11-09
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Terminally Ill Patients

Keywords

Mobile technology devices, Terminally ill patients in critical care

Brief summary

By developing a smart mobile shared decision-making (SDM) model, this study aims to assist family members of critically ill end-stage patients in making appropriate decisions, enhance their decision quality, and evaluate the model's effectiveness

Detailed description

This study utilized a single-blind experimental design and was conducted in the intensive care unit (ICU) of a medical center in northern Taiwan. The study participants were family members responsible for making end-of-life decisions for patients diagnosed with terminally ill critical conditions. Participants were randomly assigned to either the experimental or control group using block randomization software. A total of 70 participants were enrolled, with 35 assigned to the experimental group and 35 to the control group

Interventions

OTHERExperimental: Mobile technology devices

Phase 1 primarily involved scheduling the family meeting and providing decision aids. Family members used smartphones or tablet computers to download a mobile health application or scanned a QR code to access the content. They were instructed to complete reviewing the materials prior to the next phase. Phase 2 took place within three days, during which the medical team and family members convened a family meeting in the ICU conference room. The team accompanied the family in watching an approximately four-minute video titled 'End-of-Life Options,' explained the details of end-of-life care, and assisted them in selecting appropriate care plans

Sponsors

CHIA-HUI MA
Lead SponsorOTHER
Mackay Memorial Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants were randomly assigned to either the experimental group or the control group using block randomization software. Family members were blinded to the group allocation

Intervention model description

Randomly assigned to an experimental group and a control group.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

-Patients diagnosed with terminal cancer or the eight designated non-cancer terminal diseases. Patients determined to have a terminal and irreversible condition by two attending physicians. Primary family decision-makers who are aged 20 years or older and provide informed consent to participate in the study. Able to communicate in Mandarin or Taiwanese and possess basic literacy skills.

Exclusion criteria

* Cases where all family members reside abroad and have appointed an alternative healthcare proxy. Those who have already received end-of-life decision-making consultations prior to ICU admission. Patients who already have a Do Not Resuscitate (DNR) status annotated and have confirmed their end-of-life care preferences.

Design outcomes

Primary

MeasureTime frameDescription
Decisional Conflict7daysTo evaluate the changes in decisional conflict among family members."The Decisional Conflict Scale (DCS) was employed to measure participants' uncertainty in making choices. The scale comprises 16 items across five subscales, with a total score exceeding 37.5 indicating significant decisional conflict. The instrument has demonstrated robust internal consistency (Cronbach's alpha = 0.78 - 0.92)."

Countries

Taiwan

Contacts

STUDY_CHAIRMA C HUI

Mackay Memorial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026